drugset / Trial / NCT00959946

Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

NCT00959946

Phase 1/2 Terminated 32 enrolled Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2. In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.

Timeline

Start
2009-09
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosutinib Small molecule 200 mg Oral
Subject Bosutinib Small molecule 200 mg/m2 Oral
Subject Bosutinib Small molecule 300 mg Oral
Subject Capecitabine Small molecule 625 mg/m2 Oral
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral